It’s been quite a year or two at the FDA since Commissioner Hamburg took over.  Of particular interest to me is their increasingly tough stance on inspections and marketing issues.  Here are some highlights:

  • The FDA wants to prosecute pharma and device execs should their firms engage in off-label marketing.  With what is known as the Park Doctrine, execs could face up to a year in jail + $100,000 fines.  This would be on top of the billion-dollar+ fines the companies have paid (which have not dissuaded them from trying to get away with things).
  • FDA Chief Litigation Officer Blumberg was quoted as saying last month: “if you are a corporate executive – or counsel advising such a client – I would not wait for the first case to decide now is the time to comply with the law. They won’t get a mulligan on their conduct.”  And it looks like he kept his promise – a former Glaxo lawyer was indicted 2 weeks ago for essentially lying to the FDA about their off-label marketing activities.
  • The FDA continues to bypass legal review for the issuance of warning letters, though this policy is allegedly being re-evaluated now.  Some have criticized this policy for allowing for more, sloppier, and more “legally dubious” warning letters.  Nonetheless, the policy continues in an effort to streamline their warning letter process as they anticipate more warning letters coming through.
  • A quick search on our 483s listing show that the number of 483s in 2009 and 2010 issued by the FDA will end up being ~10,000/year.  This is compared to 7-8k in 2007 and 2008.
  • Do a few searches on “Japan” or “China” in our 483s listing, and you’ll see a dramatic increase over the last few years. (no surprise, since they announced they’d do ~2,000 international inspections in 2010).
  • Pharma companies will increasingly need to answer for their contract manufacturers.  Hey, the quality of the final product is still the responsibility of the sponsor, not the vendor, right?
  • A lot of people talk about how the FDA has hired a ton (hundreds?) of new inspectors and that the FDA FY11 budget is almost 2x that of FY08.  I think a lot of that just comes with an increasingly complex world (both with science and with globalization).  But make no mistake about it, the FDA under Hamburg will only get more aggressive.  While she has already instituted a lot of changes, changing an organization the size and complexity of the FDA takes time.  So, expect a lot more in the next few years.
  • Unilateral authority, mandatory recalls, and consent decrees, oh my!  A lot of chatter here, but not much action yet.  Mandatory recalls are stuck in proposed bills, but could still happen.  You have to admit that it’s a little weird that the CPSC can recall a children’s toy, a camping stove, a motorized awning, and yet the FDA can’t recall drugs.  A bill to provide the FDA unilateral authority to shut down farms that have tainted product is also sitting in D.C., though this one has gotten some traction with all the massive food recalls this past year.  Consent decrees (good intro here) have been utilized many times over the years, but many do not have firm close-outs (here’s a list of 16 “black hole” consent decrees).   Some have argued that the FDA has struggled with “enforcement inflation”, with consent decrees as the latest “don’t call my bluff” that’s been called.    Nonetheless, even if the 2 bills get stalled in Congress, expect the FDA to increasingly utilize consent decrees (and do-not-pass-go jail cards) for repeated unaddressed issues.

What other ways have you seen the FDA get tougher these last couple of years?  What are your predictions for next year?

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